New TGA Regulations Around Orthopaedic Injections

Orthopaedic Surgeons and Sports Physicians

New TGA Restrictions on advertising come into effect as of the 1st July 2018

All Autologous human cell and tissue (HCT) products that include

PRP Injections,

Stem Cell Therapy and

Cartilage Transplant

are included in the restriction.

What's changing?

Advertising to consumers of autologous HCT products, similar to the prohibition in Australia of the advertising of prescription medicines, but noting that services (that do not mention specific products) will still be permitted to be advertised.

Autologous human cell and tissue (HCT) products are those that are removed from, and applied to, the same person, i.e. the donor and the recipient are the same. These include some products commonly referred to as 'stem cell treatments'

Certain autologous human cell and tissue products have not been captured by TGA regulatory oversight, because historically they have been seen as part of medical practice. However, there is growing global concern for patient safety due to the increasing complexity of treatments offered.

Medical practitioners could undertake high levels of manipulation on cells and tissues (more akin to manufacturing) while still being excluded from TGA regulation

Consumers may be misled about unproven treatments by direct to consumer advertising

Following public consultation on the regulation of autologous human cell and tissue products in 2015 and 2016, the Government has decided to change the regulation of human cells and tissues for autologous use under the supervision of a medical or dental practitioner. As a result of the changes, a larger proportion of these products will become subject to regulation by the TGA, with the level of regulation being determined by the risk posed to patient safety.